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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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AtriCure Isolator Synergy Clamp and Guide System - 10840143905834

Surgical Ablation System Open, Long Jaw with Glidepath Magnetic Guide
ATRICURE, INC.
OLH
In Commercial Distribution

  • 10840143905834 ()
  • 10840143905193 ()
  • 30840143904800 ()
  • 50840143904064 ()
A001143SB

  • Cardiac radio-frequency ablation system generator

AtriCure Isolator Synergy EnCompass Clamp and Guide System - 10840143905520

Glidepath Magnetic Guide
ATRICURE, INC.
GPM100
In Commercial Distribution

  • 10840143905520 ()
  • 30840143904824 ()
  • 50840143904088 ()
  • 10840143904134 ()
A001212SB

  • Cardiac radio-frequency ablation system generator

ABS HOOK AND LOOP PAD - 00842430115455

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
160-0011
Not in Commercial Distribution

  • 00842430115455 ()
  • 10842430115452 ()
  • 00869284000225 ()
600-0016

  • Multi-purpose surgical skin adhesive tape

PuraPly™ Wound Matrix - 00618474000077

PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for the management of wounds. PuraPly™ Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-012
In Commercial Distribution


  • Width: 9 Centimeter
  • Length: 6 Centimeter


  • Animal-derived wound matrix dressing

Short Throw - 00724995182472

The Short Throw snare is an electrosurgical device used to grasp, dissect and transect tissue during gastrointestinal endoscopic procedures, and used with diathermic energy.
US Endoscopy
00711018
In Commercial Distribution

  • 10724995182479 ()
  • 00724995182472 ()
  • 00816765010839 ()

  • Length: 230 Centimeter
  • Outer Diameter: 2.4 Millimeter
  • Width: 1 Centimeter
00711018

  • Uterine manipulator, single-use

DuraSeal® Exact - 10381780542186

DuraSeal® Exact Spinal Sealant System Polymer Kit 3mL
Integra Lifesciences Corporation
206320
In Commercial Distribution

  • 30381780542180 ()
  • 10381780542186 ()
  • 10381780000037 ()

  • Total Volume: 3 Milliliter
206320

  • Dura mater sealant

HeartMate 3™ - 05415067038456

Sealed Outflow Graft with Bend Relief
Thoratec Corporation
105581US
In Commercial Distribution

105581US

  • Implantable ventricular circulatory assist system outflow cannula, animal-derived

External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima - 00817495024554

External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
Candela Corporation
KT77911
In Commercial Distribution

KT77911

  • Dermatological laser beam guiding handpiece

Intima Sterile 2 Internal + 1 External HP, Accessories Kit - 00817495024523

Intima Sterile 2 Internal + 1 External HP, Accessories Kit
Candela Corporation
KT78011
In Commercial Distribution

KT78011

  • Dermatological laser beam guiding handpiece

Standard 64 Sublative iD, (100 Pulse), Sterile - 00817495024493

Standard 64 Sublative iD, (100 Pulse), Sterile- eTwo
Candela Corporation
AS79253
In Commercial Distribution

AS79253

  • Multi-modality skin surface treatment system
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